CERSI‑AT: practical guidance for decentralized manufacturing
Cell & Gene Therapy Insights 2026; 12(4), 423–445
DOI: 10.18609/cgti.2026.047
CERSI-AT, coordinated by the Cell and Gene Therapy Catapult, advances regulatory science to strengthen decision-making for ATMPs. Through structured stakeholder engagement, pilot projects, and targeted outputs, including white papers and regulatory briefings, it aims to streamline ATMP pathways and position the UK as a global leader in advanced therapy innovation.
Decentralized manufacturing (DM) is emerging with its potential to enable timely access of medicines, including advanced therapy medicinal products (ATMPs), which have with a very short shelf life or are very personalized to the recipient. In 2025, the UK introduced a regulatory framework that permits DM via Modular Manufacture (MM) or Point of Care (POC) pathways. In this article, CERSI-AT has created practical guidance for developers planning DM in the UK. Illustrative examples deliberately extend beyond formal Medicines and Healthcare products Regulatory Agency (MHRA) guidance to stimulate strategy development and implementation planning.
Key technical, operational, and regulatory challenges associated with implementing DM across distributed sites are examined, including maintaining consistent quality, ensuring robust supply chains, achieving process comparability, and coordinating quality systems Mitigation strategies are proposed, grounded in risk-based control, standardization, digital integration, and enhanced process understanding, alongside the importance of early regulatory engagement and lifecycle planning. Additionally, critical regulatory components are described, such as the DM designation process, Good Manufacturing Practice considerations, and the role of the Decentralised Manufacturing Master File (DMMF) in supporting oversight and compliance.